Biotility: Lead Document Controller

The module defines document control and describes its purpose. It identifies and classifies records that are part of the document control process, including batch records and standard operating procedures (SOPs). The module also explains the life cycle of document control, including proper preparation of written documents, documentation review, and records management.

Recommended Use: Required
ID (Language): 22409 (English)
Author(s): Marie Conzone, BS - Cadence Florida

The module discusses Good Documentation Practices (GDP) and their importance to quality assurance. It details the rules of GDP for recording and correcting information. The module explains ALCOA principles (Attributable, Legible, Contemporaneous, Original, and Accurate) and discusses how they can help ensure data integrity. The module concludes with a description of the relationship between Current Good Manufacturing Practices (CGMP) and GDP.

Recommended Use: Required
ID (Language): 22410 (English)
Author(s): Marie Conzone, BS - Cadence Florida

The module discusses the central purposes and responsibilities of a document controller. It describes the primary methods for organizing paper and electronic documents. The module examines the functions and types of electronic document management systems (EDMS). It also identifies the essential experience, skills, and educational requirements for entry-level positions in document control.

Recommended Use: Required
ID (Language): 22411 (English)
Author(s): Marie Conzone, BS - Cadence Florida

The module describes the role and responsibilities of a lead documentation controller and details the benefits of having one. It identifies challenges in documentation control and the best ways to address them. The module examines documentation control software and its applications. It details the skills, education, and experience needed to become a lead documentation controller and discusses the importance of soft skills and project management for that role.

Recommended Use: Required
ID (Language): 22412 (English)
Author(s): Marie Conzone, BS - Cadence Florida